Synthetic whole blood

Abstract

A composition and a method of making a whole blood substitute are disclosed. The claimed invention duplicates the two phase heterogeneous physico-chemical system of natural whole blood and accordingly, is capable of carrying out virtually all of the physiological functions of whole blood. Albumin dispersed in a solution composed of distilled water, sodium chloride and urea, and to which a surface active agent such as lecithin is subsequently added, constitutes the preferred method of preparing the two phase aqueous liquid system on which this invention is based. Other ingredients necessary to the manufacture of the claimed composition of matter include stroma free hemoglobin, an appropriate sterol, electrolytes and proteins. Emulsification of the two phase aqueous liquid system and the additives given immediately above completes the preparation of the claimed synthetic whole blood. The method of manufacture described in this disclosure also provides for the separation of the phases of the two phase aqueous liquid system. Separation of the coacervate phase from the external equilibrium phase may be carried out prior to the introduction of the additives referred to above. In the preferred procedure, separation takes place after emulsification has been completed. Introduction of the claimed synthetic whole blood into the circulation is accomplished through intravenous transfusion. When introduced into the circulation, the coacervate phase of this invention will serve the functions of normally occuring hematocrit.

What is claimed is: 
     
       1. A semi-prepared synthetic whole blood product comprising about 0.855-0.675% weight to volume NaCl, about 0.75-4.75% weight to volume urea, about 0.0075-9.5% weight to volume of a phospholipid, about 63.07-73.5% weight to volume H 2  O, and about 5-25% weight to volume albumin,said components forming a coacervate system having a coacervate phase and an equilibrium bulk water phase. 
     
     
       2. The semi-prepared synthetic whole blood product of claim 1, wherein the phospholipid is lecithin, cephalin, isolecithin, sphingomyelin, phosphatidyl serine, phosphatidic acid, phosphatidyl inositol, phosphatidyl choline or mixtures thereof. 
     
     
       3. The semi-prepared synthetic whole blood product of claim 2, wherein the phospholipid is lecithin. 
     
     
       4. The coacervate phase of the semi-prepared synthetic whole blood product of any one of claims 1-3, said coacervate phase comprising a semi-prepared synthetic substitute for hematocrit. 
     
     
       5. The coacervate phase of claim 4, including a sterol, CaCl 2 , KCl, stroma free hemoglobin, enzymes, proteins, nutriments, or mixtures thereof. 
     
     
       6. The coacervate phase of claim 5, wherein the sterol is cholesterol, ergosterol, 7-dehydrocholesterol, α sitosterol, β sitosterol, γ sitosterol, campesterol, or mixtures thereof. 
     
     
       7. A synthetic whole blood according to claim 1, comprising about 95-75% weight to volume of the semi-prepared synthetic whole blood product, about 5-25% weight to volume of water, and a small amount of NaCl, said synthetic whole blood thereby being isotonic with natural whole human blood. 
     
     
       8. A synthetic whole blood according to claim 2, comprising about 95-75% weight to volume of the semi-prepared synthetic whole blood product, about 5-25% weight to volume of water, and a small amount of NaCl, said synthetic whole blood thereby being isotonic with natural whole human blood. 
     
     
       9. A synthetic whole blood according to claim 3, comprising about 95-75% weight to volume of the semi-prepared synthetic whole blood product, about 5-25% weight to volume of water, and a small amount of NaCl, said synthetic whole blood thereby being isotonic with natural whole human blood. 
     
     
       10. The synthetic whole blood of claim 7, having a pH of about 7.3 to 7.45. 
     
     
       11. The synthetic whole blood of claim 8, having a pH of about 7.3 to 7.45. 
     
     
       12. The synthetic whole blood of claim 9, having a pH of about 7.3 to 7.45. 
     
     
       13. The synthetic whole blood of claim 10, wherein the pH is achieved by the addition of sodium bicarbonate. 
     
     
       14. The synthetic whole blood of claim 11, wherein the pH is achieved by the addition of sodium bicarbonate. 
     
     
       15. The synthetic whole blood of claim 12, wherein the pH is achieved by the addition of sodium bicarbonate. 
     
     
       16. The synthetic whole blood according to claim 13, including a sterol, CaCl 2 , KCl, stroma free hemoglobin, enzymes, protiens, nutriments, or mixtures thereof. 
     
     
       17. The synthetic whole blood according to claim 14, including a sterol, CaCl 2 , KCl, stroma free hemoglobin, enzymes, proteins, nutriments, or mixtures thereof. 
     
     
       18. The synthetic whole blood according to claim 15, including a sterol, CaCl 2 , KCl, stroma free hemoglobin, enzymes, proteins, nutriments, or mixtures thereof. 
     
     
       19. The synthetic whole blood of claim 16, wherein the sterol is cholesterol, ergosterol, 7-dehydrocholesterol, α sitosterol, β sitosterol, γ sitosterol, campesterol, or mixtures thereof. 
     
     
       20. The synthetic whole blood of claim 17, wherein the sterol is cholesterol, ergosterol, 7-dehydrocholesterol, α sitosterol, β sitosterol, γ sitosterol, campesterol, or mixtures thereof. 
     
     
       21. The synthetic whole blood of claim 18, wherein the sterol is cholesterol, ergosterol, 7-dehydrocholesterol, αsitosterol, β sitosterol, γ sitosterol, campesterol, or mixtures thereof. 
     
     
       22. The synthetic whole blood of any one of claims 7-21, said blood being an emulsion having droplets from 2 to 9 microns in size. 
     
     
       23. The coacervate phase of the synthetic whole blood of any one of claims 7-21, said coacervate phase comprising a synthetic substitute for hematocrit.